Hello Carl and Marty. I too see how this string can be leading into a debate over the motives of development of such a product and the literal questioning of science. We really do try to make an effort to minimize such debates, the reasons explained in our mission statement. But when new products are just being released or a new product is on the horizon and is being touted as a panacea for smoking cessation, we feel the need to put such statements in perspective.

Carl, you caught the point I was getting at when saying you would likely die if you smoked waiting for these promises of science curing smoking to come true. But for every person who understands the subtle nuance and limitations of such announcements there are many more people who just do not put this information in proper perspective.

Where I see such announcements of science being dangerous is when scientists or the news media starts giving the impression of a cure for lung cancer is just around the corner. It is true that our science is getting ever more sophisticated and one day a cure may in fact be developed. I would say that if we were looking ahead to future generations the odds are quite good. But the odds of a cure coming out soon enough to save a smoker alive today should not be counted on--we have held out high hopes for this for a long time and are still losing hundreds of thousands of people annually from this specific disease.

Even a child reading such news today should think twice and three times before taking up smoking thinking that this cure may save his or her life if he or she would take up smoking. There is a real good chance his or her smoking parents and maybe even grandparents read or heard the same kind of hopeful news reports prior to taking up smoking too.

But don't get us wrong here when we point out the limitations of this science. I do hope that the research to find such a cure is continued and that may a cure right around the corner. I know quite a few people who are alive today battling this disease and I would be thrilled if there were a cure today introduced to save their lives. But even if that day comes while I am alive I will see it as a bitter sweet victory, for while the cure may save people from that point on, there will be countless others who I will have known who would have died because the cure was just too late--and basically millions more who I didn't know who lost their lives hoping and praying for such a cure.

We want all people here to recognize what they are doing by quitting now is the best chance they currently have to lower their odds of dying of lung cancer--and a host of other diseases. Not by curing it, but by minimizing the risk of developing it.

On the same token I do hope that one day science does come out with a way to prevent smoking, whether it be by preventive measures or treatments for current smokers. But again, I am not holding out high hopes of this happening anytime soon. The promise has been dangled out there numerous times and have basically all fallen flat.

What our members are doing here and now is the best chance they have of beating the nicotine addiction. Again, not by "curing" the addiction, but by taking control of it and rendering it harmless. The only risks posed by being addicted to a substance that you no longer administer is the risk of relapse if YOU once again admininister it. The risk of this happening though is nil if you constantly enforce your vow to never allow nicotine into your body via any route such as chewing, eating, drinking, inhaling, placing on your skin for absorption, injecting and of course the most obvious and likely route, by knowing to never take another puff!

Slough, England, June 14 (Bloomberg) -- Xenova Group Plc Chief Executive Officer David Oxlade wants to stop people from feeling good -- for all the right reasons. His company's making treatments that take the pleasure out of nicotine and cocaine.[/size]

One of the medicines, the anti-nicotine treatment TA-NIC, was safe and well tolerated in an early study, the U.K. biotechnology company said today. The vaccine produces antibodies that successfully latch on to nicotine, Oxlade said.[/size]

``The reason nicotine is addictive is that it moves so easily from the blood to the brain, where it causes so much pleasure,'' Oxlade said in an interview. ``Antibodies in the blood mop up the nicotine and prevent it from getting to the brain.''[/size]

Eight in 10 people who quit smoking start again within a year, said Oxlade, who gave up the habit 20 years ago. The health advocacy group Action on Smoking and Health says 120,000 people in the U.K. will die of smoking-related diseases this year, and that about 450 children start smoking every day.[/size]

Xenova's anti-nicotine treatment is injected into the muscle about four or five times over a two-month period, and its effectiveness should last as long as a year, the company said.[/size]

The unprofitable company is also working on a drug to treat cocaine addiction, called TA-CD. A company study showed that rats given access to the illicit drug would increasingly administer it to themselves. TA-CD slowed that process.[/size]

Oxlade said Xenova would seek a partner to help bring the treatment to the market. It will be several years before it's available for sale.[/size]

Xenova had about 17 million pounds ($25 million) in cash at the end of March, after spending about 4 million pounds last year. The anti-nicotine treatment has finished the first of three studies generally required before receiving regulatory approval, and wouldn't reach the market for several years.[/size]

The company's shares rose 75 pence, or 1.5 percent, to 51.75p in mid-morning trading. They've lost a quarter of their value this year.[/size]

I hope that none of you ran out and bought stock in TA-NIC after reading about their wonderful new nicotine vaccine. I understand that The Wall Street Journal reported today, July 5, 2002, that .... "50 smokers in Belgium were injected with an unusual drug code-named TA-NIC. After taking as many as five doses over 10 weeks, two smokers quit. Several others reported a lower desire to smoke, according to Xenova PLC, the drug's British maker."

Unfortunately, that is a higher relapse rate than if they'd been uneducated, unskilled, unsupported and uncounseled cold turkey quitters - 10 to 12% at six months and 5 to 6% at one year

We've each been reading magic cure stories for as long as we smoked nicotine. The traveling hypnotist guaranteed I'd quit - "90% success rate" the ad said. Maybe that's why I went back a few years later for a second try. I just couldn't believe that I was the 1 in 10 for whom this cure just didn't take. How are they still getting away with such outlandish performance assertions when all objective medical studies conducted to date have found no advantage for hypnosis?

All the games being played really don't matter. The bottom line is none of the magic cures to date have abated smoking's worldwide kill rate nor have any of them been effective in ending chemical dependency upon nicotine - none.

The below article is typical of hundreds of similar articles that have ran in newspapers around the world since we started this thread back in June 2002. Hardly a day goes when the major tobacco news services are not reporting the story being shared somewhere. My concern is that stories such as these are junkie rationalization fuel helping carry millions of addicts to early graves.

As shown below there are new entrants and achievements in the vaccine wars but also new problems as they have absolutely no way of proving efficacy for those who've already quit as these researchers understand the "Law of Addiction" (rewritten - never take another puff!).

This thread has produced some rather interesting observations. If science is eventually able to block 100% of nicotine from crossing the blood-brain barrier but is unable to alter the intensity or duration of the physical or psychological recovery experience, how long will it take for nicotine addicts who've taken the vaccine to realize that there are a host of illegal drugs and Rx pain medications available capable of pumping out large quantities of dopamine, whose molecule is not blocked by an effective vaccine? Sound pretty far fetched? I'm not so sure.

Nicotine has long been known as the "gateway"drug. This quote is from my state's drug abuse agency:

"Many of today's youth who smoke cigarettes will become addicted to nicotine. But that's not all. Underage smokers are much more likely than non-smokers to use alcohol and other drugs. For example, underage smokers in South Carolina are:

Today there is still only one way to allow the brain the time needed to re-sensitize itself to its own neurochemicals by normalizing the number of neurotransmitter receptors and transporters in a host of important circuits, and that's to stop putting nicotine into the brain. Will an effective vaccine someday protect the brain from being forced to accept a highly addictive natural insecticide that nature intended to kill bugs who try eating the tobacco plant? I don't know. What we do know is that this temporary journey of adjustment can be one of the most rewarding adventures of our life and it's ours to keep so long as we decide to Never Take Another Puff!

A vaccine against smoking

By Eran Shifferman

February 11, 2004, Haaretz News

A number of antidotes to nicotine, currently undergoing clinical trials, are designed to stimulate the body's immune system to create antibodies. These bind with nicotine molecules, forming a compound too large to traverse the blood-brain passage. The result is that the pleasurable effect of smoking is neutralized and the addiction to nicotine prevented. The compound later breaks down into harmless components and is excreted from the body.

Three companies have produced vaccines. The Swiss firm Cytos has developed Nicotine-Qbeta. The Xenova Group in the U.K. is testing TA-NIC, in which the active ingredient is a kind of "tagging" procedure using a nicotine derivative and an endotoxin from the cholera virus. The American firm Nabi Biopharmaceuticals has developed NicVAX with an endotoxin from a different virus.

Binding with a protein stimulates the immune system to produce antibodies to nicotine, which would not have occurred had the nicotine molecules been able to move freely in the bloodstream. All the vaccines are administered by injection.

In preliminary trials, in which rats were injected with NicVAX, a 65 percent reduction in the nicotine entering the brain was observed. The San Diego-based Scripps Research Institute (TSRI) has announced that it is developing a second-generation nicotine vaccine designed to solve a problem that has vexed researchers: the nicotine molecule is flexible enough to produce structural changes, making it difficult for antibodies to bind with it. In the new version, the nicotine derivative has been engineered for stability. TSRI researchers claim that the second-generation vaccine produces a far broader immune reaction than its predecessor.

Reservations have been voiced within the medical community regarding the success of the vaccines. Some researchers wonder about nicotine addicts increasing the number of cigarettes they smoke to the point where the antibodies are unable to cope with the quantity of nicotine taken in.

In any event, the focus of the clinical trials at this stage is on the safety of the vaccine rather than on its efficacy and its ability to prevent addiction.

An additional problem is a question of ethics: the guidelines for the trials forbid giving nicotine to someone who has already been weaned off it.

Some of the biopharmaceutical companies are simultaneously working on a vaccine against cocaine. If their experiments succeed, it will provoke a social-ethical debate about the authority of society and of parents and teachers in controlling undesirable patterns of social behavior in advance. It is unlikely that anyone will object to a vaccine against cocaine, but the debate over nicotine will be interesting to watch.

Hello Carl and Marty. I too see how this string can be leading into a debate over the motives of development of such a product and the literal questioning of science. We really do try to make an effort to minimize such debates, the reasons explained in our mission statement. But when new products are just being released or a new product is on the horizon and is being touted as a panacea for smoking cessation, we feel the need to put such statements in perspective.

Carl, you caught the point I was getting at when saying you would likely die if you smoked waiting for these promises of science curing smoking to come true. But for every person who understands the subtle nuance and limitations of such announcements there are many more people who just do not put this information in proper perspective.

Where I see such announcements of science being dangerous is when scientists or the news media starts giving the impression of a cure for lung cancer is just around the corner. It is true that our science is getting ever more sophisticated and one day a cure may in fact be developed. I would say that if we were looking ahead to future generations the odds are quite good. But the odds of a cure coming out soon enough to save a smoker alive today should not be counted on--we have held out high hopes for this for a long time and are still losing hundreds of thousands of people annually from this specific disease.

Even a child reading such news today should think twice and three times before taking up smoking thinking that this cure may save his or her life if he or she would take up smoking. There is a real good chance his or her smoking parents and maybe even grandparents read or heard the same kind of hopeful news reports prior to taking up smoking too.

But don't get us wrong here when we point out the limitations of this science. I do hope that the research to find such a cure is continued and that may a cure right around the corner. I know quite a few people who are alive today battling this disease and I would be thrilled if there were a cure today introduced to save their lives. But even if that day comes while I am alive I will see it as a bitter sweet victory, for while the cure may save people from that point on, there will be countless others who I will have known who would have died because the cure was just too late--and basically millions more who I didn't know who lost their lives hoping and praying for such a cure.

We want all people here to recognize what they are doing by quitting now is the best chance they currently have to lower their odds of dying of lung cancer--and a host of other diseases. Not by curing it, but by minimizing the risk of developing it.On the same token I do hope that one day science does come out with a way to prevent smoking, whether it be by preventive measures or treatments for current smokers. But again, I am not holding out high hopes of this happening anytime soon. The promise has been dangled out there numerous times and have basically all fallen flat.

What our members are doing here and now is the best chance they have of beating the nicotine addiction. Again, not by "curing" the addiction, but by taking control of it and rendering it harmless. The only risks posed by being addicted to a substance that you no longer administer is the risk of relapse if YOU once again admininister it. The risk of this happening though is nil if you constantly enforce your vow to never allow nicotine into your body via any route such as chewing, eating, drinking, inhaling, placing on your skin for absorption, injecting and of course the most obvious and likely route, by knowing to never take another puff!

Joel

Last edited by Joel on February 6th, 2011, 6:12 pm, edited 1 time in total.

As stated in above articles, yesterday Nabi asserted to the world that "a Phase II clinical trial showed that 33 percent of 68 smokers inoculated with the company's NicVax vaccine were able to quit, as opposed to 9 percent who took a placebo." "The company did not say how long the smokers remained smoke-free. Nabi said it will release full Phase II clinical trial results at various scientific meetings in 2005."

Nabi's press release intentionally omits some rather critical info:

How long they quit - a week, a month, three months, six months?

How quitting was defined - continuous nicotine cessation, point prevalence or some new creative definition?

What behavioral interventions, counseling and/or support were used (if any), that had their own proven effectiveness and for which NicVax should not be allowed to claim credit?

What are the results of the study's blinding assessment?

What happened to the 66% who relapsed with the vaccine still inside them - has their daily smoking actually increased?

What's most frightening is that we knew from the Phase I study that one-third of the nicotine smoked was not binding with the vaccine which we are told would have made the new molecule too large to pass through the blood brain barrier. In other words, we knew that a relapsed smoker would need to smoke roughly three times their old nicotine intake in order to have sufficient nicotine present in the brain to satisfy their old level of tolerance.

As for blinding, we just learned that a $1.4 billion dollar NRT industry has likely been built entirely upon junk science in that the studies were not blind as claimed (see - http://whyquit.com/pr/051904.html). If true, why would a psychoactive chemical (nicotine) not also be psychoactive in vaccine studies?

What are the odds that a substantial percentage of those assigned to receive the placebo in the NicVax studies remained blind to the fact that within 8 to 10 seconds of that first puff, a big big "aaahhh" sensation still arrived? Think about it. If they had joined the study in hopes of receiving this new miracle cure then what are the odds that they would have remained in the study once their expectations were dashed?

It's a bit different from realizing that they were not experiencing their dopamine/adrenaline high, as in the NRT studies, but the drug is still psychoactive and researchers in both study areas must come to terms that relying upon frustrated expectations to produce victories is not science but more closely akin to outright fraud. Frankly, I'm beginning to believe that it may be impossible to use a placebo study format when dealing with any psychoactive chemical.

Yes, thirty-three (33%) percent is a solid recovery rate but only when put in an honest and comparable context. I am light years away from having the recovery understanding of Joel in helping educate and a group of quitters yet I have yet to do a quit smoking clinic where at least 50% of participants were not still nicotine-free at two weeks. Although it has been some time science we've done an evaluation here at Freedom, our last two evals produced 38 and 39% six month continuous nicotine cessation rates for new members posting to the group at least once.

We are not limited to just analyzing the active NicVax group (those receiving the vaccome either, as we know that roughly 10% of the placebo group should have successfully quit smoking for months if they had quit entirely on their own without any products, procedures or programs (see http://whyquit.com/whyquit/A_OTCPatch.html ). If the 9% in the Nabi study was for a period shorter than 6 months, or if counseling or group support was used as part of the study (both of which produce effectiveness in their own right) then it would seem to suggest that the placebo group may have sustained some degree of expectations defeat.

The NicVax study press releases have generally been less than forthright, omitting substantial detail that would have allowed smokers to better evaluate the vaccine's merits, if any. It is my guess that a creative definition of quitting is being employed. Why? Well, the very foundation of a vaccine is that it inoculates the user against risks posed by a known harm. If a smoker now believes that they can smoke nicotine but that the nicotine will not enter their brain then shouldn't we expect some precentage to try and test or challenge the vaccine now and then?

If so, wow do we come up with a quitting definition that will allow them to do so yet also allow the researchers to proclaim to the world that they quit? In NRT studies many researchers employed a quitting definition called "point prevalence" which only asked if the quitter had quit smoking during a particular time period, almost always the "point" in time -- and a stated number of days preceding -- when they were scheduled to have their next appointment at the study center for a quitting evaluation, an event which many studies paid participants financial compensation.

As you know, the NRT studies actually invented their own creative definition of quitting. No longer was continuing to be hooked on nicotine a concern as up to 7% of gum users still dependent upon the gum at six month were declared to have successfully quit. Now that science was able to extract nicotine from the tobacco plant and put it into new and creative delivery devices, for the very first time quitting smoking no longer required the addict to quit nicotine too.

What is troubling about past vaccine press releases is that they vastly over-inflated expectations. We each know that thousands of junkie minds are searching for a way to rationalize continued smoking. Those who attempt to convince them that a cure is just a few years away may actually be contributing to helping cost thousands their health and quality of life or, worse yet, life itself.

Overall the vaccine researchers have been extremely irresponsible by not telling nicotine addicts not to wait on "possibilities" but to quit now and quit today. I get mad at myself for even thinking such thoughts but with certain stories I was left with a deep hurt upon feeling that they almost wanted smokers to delay cessation.

After ten days to two weeks nicotine dependency recovery is almost entirely psychological. Pharmacology continues to all but ignore this reality. It would be fantastic if we could safely inoculate the world's children against nicotine addiction but don't hold your breath as it is not happening here.

Still only one rule for me as well as you, no nicotine just one day at a time ... Never Take Another Puff! John (Gold x5)

The below TA-NIC press release presents far more questions than answers. Here are a few of mine.

1. If only one-third of nicotine smoked is able to pass the blood brain barrier once the "vaccine" is taken, what change in the number of cigarettes smoked per day has occurred to the 81% of 250 ug TA NIC users who reported relapse?

2. Why would a study as scientic as this rely upon the honor system and "self reporting" by participants instead of conducting either expried carbon monoxide or blood or urine cotinine testing?

Nicotine is a teratogen in rats and possibly in humans. Vaccination against nicotine is being studied as a possible treatment for nicotine dependence. The safety of maternal vaccination against nicotine during or prior to pregnancy is not known. In this study, female rats were vaccinated and then administered acute or chronic nicotine during pregnancy at doses simulating nicotine exposure in smokers.

Maternal vaccination reduced nicotine distribution to both maternal brain (44-47%) and fetal brain (17-39%) for up to 25 min after a single maternal nicotine dose administered on gestational day (GD) 20, but had a smaller effect on nicotine distribution to brain after continuous nicotine infusion.

Nicotine distribution to maternal or fetal brain after repeated nicotine bolus doses was reduced immediately following an individual dose in vaccinated rats, but the chronic accumulation of nicotine in fetal brain was not altered. Nicotine distribution to whole fetus, in contrast to fetal brain, was generally not altered by vaccination. Nicotine-specific antibody concentration in fetal serum was 10% that of maternal serum, and in fetal brain was <1% of maternal serum.

Although nicotine transfer to the whole fetus was not reduced by vaccination, protein binding data suggest that nicotine-specific antibody transferred from mother to fetus served to bind nicotine in fetal serum, reduce the unbound nicotine concentration, and thereby reduce nicotine distribution to fetal brain. These data comment on the safety of vaccination against nicotine during pregnancy, and suggest that vaccination may reduce the distribution of nicotine to fetal brain under some nicotine dosing conditions.

If I read this correctly the results point to some limited effectiveness with the nicotine blocking vaccine. Certainly not a total solution or unqualified success.

I wonder why a more holistic solution is not considered. Instead of adding another drug or agent to a person's blood chemistry, who not remove the chemical that is not suppoed to be there to begin with?

Becoming and staying nicotine free IS an expedient and available option for all who choose to live as the were meant to be. Naturally.

Keep in mind that there are at least two products here, NicVax and Ta Nic. The below article is about Ta Nic but both products seem to be working with the "higher dose" now. If true and producing just 16% smoking cessation at one year, that's 5 points less than varenicline (Chantix & Champix) at 21%.

But if interested in making semi-valid comparisons among products that have never actually gone head to head, it's critical to keep an eye on a few additional factors: (1) participant expectations going into the study: what did the informed consent process and risk explanations prior to randomization or study recruiting prepare smokers to expect? (2) the ease or difficulty of determining group assignment: could you tell that some amout of smoked nicotine was not arriving in the brain, was the expected dopamine "aaah" sensation significantly smaller than normal, or if in the placebo group were your "aaahs" the same as before and you simply kept smoking and never quit; and (3) education, counseling, study contacts (brief quitter pep rallies) and group support, each having their own effectiveness, independent of the products being evaluated. How much study contact was there, when was it received, and at the time received, what percentage of each group was still present and fully participating in the study; if one group was then substantially larger than the other, did these independent cessation factors influence that group's overall success rate to a greater degree?

The 26 provider counseling and/or support contacts in Pfizer's varenicline studies were very likely a record, the most ever in any quit smoking clinical trial. But I get the feeling that Ta Nic and Nic Vax were trying to stand more on their own with vastly less user contact. Still, as to blinding and expectations both the vaccines and varenicline present rather interesting issues.

In NRT trials, most of the active group (those receiving replacement nicotine) could sense some level of easing off of the underlying current of withdrawal anxieties which was most stable with the patch but more noticible with oral and nasal nicotine, which was often administered in reaction to urges and craves. The more times the smoker had previously tried to quit and experienced the onset of full blown withdrawal the more they would have come to recognize their withdrawal syndrome.

Varenicline is closer to the effects of nicotine, sitting upon and blocking the exact same acetylcholine receptors nicotine would have occupied, while causing 35 to 60% of the dopamine flow nicotine would have generated. After day 5 of using varenicline, when it gets up to therapeutic levels, some user emails to me have described smoking a cigarette as if smoking a carrot - it does absolutely nothing for you, as you don't get the normal and expected "aaah" sensation."

This is why any suggestion that varenicline trials were "blind" and users could not correctly guess their group assignment is likely the biggest hoax smoking cessation has "yet" seen. The pharmaceutical industry was allowed to get away with NRT studies not being blind and appears to have become embolden by it.

What Pfizer is not telling users is that some day soon they'll stop taking varenicline, the dopamine flow it generates will end, and that in clinical trials half who succeeded in using it for 12 weeks thereafter relapsed to smoking.

But turning to blinding in Nic Vax and Ta Nic trials, the active vaccine group had a bit different experience than with NRT or varenicline. Instead of a somewhat diminished withdrawal syndrome or having up to 60% of the dopamine flow that nicotine provided (and 24 hours a day), in theory, vaccine users experience full-blown nicotine withdrawal, as if a member of the placebo group in an NRT or varenicline study, but with one big difference, what would normally have been relapse via smoking nicotine did not cause a dopamine "aaah" explosion in the brain 10 seconds later. How could an event such as this go unnoticed by any nicotine addict? It doesn't.

As with varenicline I can't see how vaccine researchers can, with a straight face, proclaim these studies blind. As with varenicline, it is not a matter of "guessing" your study group assignment but actual knowledge that a foreign chemical is present in your body and that your normal smoking experience has been seriously altered.

As for placebo group blinding, it too is somewhat unique in that some degree of motivation to quit smoking was to flow from cigarettes not providing their normal effect - relief from the onset of early withdrawal. Again, it's hard to believe that most placebo group members wouldn't have known their assignment.

But knowing group assignment is not the end of the analysis as to whether or not the study's results are valid. The question becomes, did assignment awareness combine with expectations to influence the participant's actions? In other words, if you volunteered for a study after learning it involved testing of a new "medication" and that you could get a free 12 week supply of the "medication," how would you react to actual knowledge that you were in fact getting it, or that you were not getting it?

If assigned to the placebo group and either still smoking or enduring full blown nicotine withdrawal, would you have stuck around for 12 weeks, 6 months or a year and allowed researchers to toy with you? In the active group, if your expectations had been met and you could actually feel the medication producing a totally new or somewhat different cessation experience, would such knowledge have given you new hopes, extra resolve and had you staying around longer than you otherwise would have, to try even harder and actually return for the study's next scheduled visit?

My reason for writing the above is to try and aid you in seeing that things are not always as represented, that should you feel your resolve weakening, that all these news articles and advertisements about new magic cures will hopefully not play even a minor role in inviting relapse. For what we do know is that in all real world quitting method surveys these products have yet to perform better than uneducated and unsupported "one your own" quitting.

We've each now arrested our dependency and there is absolutely no guarantee that any of us could ever come this far and heal this much again. There's only one way to stay on this side of the bars while keeping our now arrested dependency on the other ... no nicotine today, Never Take Another Puff, Dip or Chew!

An anti-nicotine vaccine will be tested on 400 people in the Nordic countries over the next year aimed at helping smokers kick the habit, the Karolinska Institute in Sweden said on Monday.

"A Swedish vaccine against nicotine will be tested on 400 people in three Nordic countries," the institute said in a statement.

Lena Wikingsson, head of Independent Pharmaceutica, which is running the experiment, told Swedish daily Svenska Dagbladet that people taking part in the study -- heavy smokers who would like to quit -- would be given counselling before they stop smoking and would be given a drug to help them quit.

They will then receive one injection a month for four months. Half of the participants will be given the vaccine and the other half a placebo.

They will be followed for a year to see whether they begin to smoke again, Wikingsson said.

The vaccine, called Niccine, has been developed over the course of 10 years by Swedish researchers at the Karolinska Institute, under the guidance of professor Torgny Svensson who founded Independent Pharmaceutica.

Niccine is supposed to help the immune system build antibodies against nicotine.

If a person who has taken the vaccine smokes a cigarette, the antibodies jump into action, latching onto the incoming nicotine and preventing it from reaching the reward system in the brain -- thereby stopping the smoker from getting the "kick" that makes smoking addictive.

One problem in developing nicotine vaccines is that the immune system doesn't react to normal nicotine.

In order to activate the immune system, the nicotine in the vaccine needs to be latched onto a "carrier" or "host" that stimulates the immune system to create as many antibodies as possible.

For the vaccine to be successful, a large number of antibodies must be created, and the carrier component is therefore the key part of Niccine, Wikingsson said.

"There are several possible applications if the vaccine proves to be effective," Wikingsson told Svenska Dagbladet.

Each new smoking cessation study seemingly sinks the integrity of smoking cessation researchers even lower. Is it fair to expect otherwise when the vast majority of researchers are financially beholden to the pharmaceutical industry for income? Think about it, if truthful yet negative words, analysis or spin were to cost the industry millions or even billions in profits, what likelihood is there that that researcher would ever work for the industry again?

Let me share the most recent example, a Phase II study published on January 26, 2011 on Nabi's new quit smoking vaccine, NicVax. The study shares 6 and 12 month smoking cessation rates of quitters receiving 4 or 5 placebo injections sought over 6 months, to the rates generated by groups receiving 4 or 5 NicVax injections at two different dose levels ( 200ug or 400ug).

According to the paper, the way the vaccine works is that:

"Nicotine conjugate vaccines stimulate the immune system to develop nicotine-specific antibodies (Abs) using an immunogen comprised of nicotine covalently linked to a larger carrier protein. Conceptually, the mechanism of action is antinicotine Abs binding to nicotine molecules, and the resulting complex is too large to cross the blood–brain barrier. With increasing Ab levels, more nicotine is captured and sequestered in the blood and prevented from entering the brain, leading to a lowering of the reinforcing effects of nicotine. "

First, take a look at the official study abstract published in PubMed, contrasting my above title to the language highlighted below in red.

Immunogenicity and Smoking-Cessation
Outcomes for a Novel Nicotine Immunotherapeutic

Department of Psychiatry, University of Minnesota Tobacco Use Programs, Minneapolis, Minnesota, USA.

Abstract

NicVAX, a nicotine vaccine (3'AmNic-rEPA), has been clinically evaluated to determine whether higher antibody (Ab) concentrations are associated with higher smoking abstinence rates and whether dosages and frequency of administration are associated with increased Ab response.

This randomized, double-blinded, placebo-controlled multicenter clinical trial (N = 301 smokers) tested the results of 200- and 400-µg doses administered four or five times over a period of 6 months, as compared with placebo. 3'AmNic-rEPA recipients with the highest serum antinicotine Ab response (top 30% by area under the curve (AUC)) were significantly more likely than the placebo recipients (24.6% vs. 12.0%, P = 0.024, odds ratio (OR) = 2.69, 95% confidence interval (CI), 1.14-6.37) to attain 8 weeks of continuous abstinence from weeks 19 through 26.

This study demonstrates, as proof of concept, that 3'AmNic-rEPA elicits Abs to nicotine and is associated with higher continuous abstinence rates (CAR). Its further development as a treatment for nicotine dependence is therefore justified.

PMID: 21270788 [PubMed - as supplied by publisher]

PubMed Link: http://www.ncbi.nlm.nih.gov/pubmed/21270788
Is it fair to say that the study's authors wanted to leave us with the impression that the NicVac nicotine vaccine is a resounding success, actually doubling the placebo group's rate (24.6% at 6 months versus 12%)? There's only one problem, the language I've highlighted in blue above, that these were the results from the top 30% within the NicVax groups whose immune systems showed the greatest response in creating nicotine antibodies, regardless of the number of injections received (4 or 5), and regardless of dosage (200ug or 400ug).

The obvious question becomes, how did the far greater 70% who also received NicVax injections do? Let me quote from the study:

High-Ab responders to 3′AmNicrEPA were defined as the top 30% of responders by area under the curve (AUC) (0–26 weeks) and the low-Ab group as the bottom 70% of responders. 3′AmNic-rEPA recipients in the high-Ab group were significantly more likely to attain 8 weeks of continuous abstinence from smoking from weeks 19 through 26 than were those receiving placebo (24.6% vs. 12.0%, P = 0.024, odds ratio (OR) = 2.69, 95% confidence interval (CI), 1.14–6.37). No significant differences in results were observed between the 3′AmNic-rEPA low-Ab group and the placebo group (9.3% vs. 12.0%, P = 0.46). As a secondary outcome, continuous abstinence rates (CAR) to 52 weeks were evaluated from weeks 19–52; these were significantly higher in the high-Ab group relative to the placebo group (19.7% vs. 10.0%, P = 0.044, OR = 2.64, 95% CI 1.03–6.79); in contrast, there was no significant difference in results between the low-Ab group and the placebo group (7.1% vs. 10.0%, P = 0.43).

Yes, you are reading that correctly. Placebo group six month (26 week) quit smoking rates were actually higher than among the 70% of quitters whose immune systems generated the lowest antibody response, generating a 12% six-month placebo quitting rate versus only 9.3% for those receiving NicVax. Placebo won again at one year with a 10% quit smoking rate versus only 7.1% among 70% of NicVax quitters receiving 4 or 5 injections.

What's also troubling is that the study provides no discussion within the full-text of the study as to how to identify which smoker would be among the 30% whose immune system would generate sufficient nicotine antibodies so as to achieve results comparable to those shared in the study's abstract (summary). It also fails to explain why the study's authors chose 30% instead of some other percentage. Is it coincidental that they chose a cutoff that resulted in doubling placebo group rates, the same "double your chances" marketing used for nicotine replacement products?

Also troubling is the fact that researchers failed to report on the validity and integrity of the study's blind. I suspect that they either didn't conduct a blinding assessment or failed to report results because they would have been compelled to tell us that among the placebo group that 3 to 4 times as many participants correctly guessed their randomized group assignment to placebo as would have guessed wrong.

Truth is, placebo group expectations do not change simply because the active group is testing and using a new quitting product. If an experienced quitter, they joined hoping to get the vaccine and see some difference in their withdrawal sydrome. When it didn't happen, participants with lengthy quitting histories, who were experts at recognizing their withdrawal syndrome, grew frustrated. How many dropping out, helping hand NicVax an unearned victory by default? Would you have returned for 4 more injections of sugar water? Neither did some of them, and all of these researchers know it.

It's why medicalization of smoking cessation has brought decline in the U.S. smoking rate to a standstill (a steady 21% of U.S. adults have remained smokers during the past five years). You see, out here in the real-world placebo isn't a real quitting method.

What researchers need to do is stop offering study quitters the worst quitting method on earth (placebo) and begin pitting these products against real cold turkey quitters, quitters who fully expect to endure and move beyond withdrawal. But that can't and won't happen. Why? Because while their products consistently prevail over placebo inside randomized clinal trials, cold turkey quitters have prevailed in nearly evry long-term real-world quitting method survey to date. Honest quit smoking studies would cost the pharmaceutical industry billions in profits.

I want to share one last item from this NicVax study. These are the names of the study authors:

And what follows is the financial conflicts disclosure statement from the full-text of the study.

Conflict of Interest

R.C.A., R.E.F.F., P.D.K., M.W.K., and M.N. are employees of Nabi Biopharmaceuticals and have received salary support, stock, and stock options. All other authors were investigators on the clinical trial funded by NIDA and by Nabi Biopharmaceuticals, and some served on an advisory panel. D.E.J. has received research support from Pfizer. D.G. owns shares of Pfizer and has received grant/research support from Pfizer, Addex Pharmaceuticals, Sanofi-Aventis, and GlaxoSmithKline; consulting fees and honoraria from Pfizer, GlaxoSmithKline, and Evotech NeuroSciences; and speaker fees from Pfizer. N.A.R. has received research grant support from Pfizer and is an unpaid consultant to Pfizer and Free & Clear. E.D.G. has received grants from and served as a speaker and consultant for Pfizer. He has also provided advice to or is on the advisory board/panel of Pfizer. He has also served as a speaker for Nabi Biopharmaceuticals. C.A.O. has received grant funding from Pfizer. S.I.R. has participated as a speaker in scientific meetings and courses under the sponsorship of AstraZeneca, GlaxoSmithKline, and Pfizer; has served as consultant for several pharmaceutical companies with relevance to the topics noted in this study (Almiral, Altana, Amersham, Array Biopharma, AstraZeneca, Aventis, Boehringer Ingelheim, Critical Therapeutics, GlaxoSmithKline, Globomax, Intermune, Merck, Novartis, Ono, Otsuka, Roche, Sanofi, Scios, Wyeth); serves on advisory boards of Altana and Pfizer; has been sponsored by GlaxoSmithKline to conduct several clinical trials and received laboratory support; has conducted clinical trials sponsored by Roche, Pfizer, Sanofi, and Novartis; has conducted both clinical trials and basic studies under the sponsorship of Centocor; and has conducted basic studies under the sponsorship of AstraZeneca. This paper was presented in part at the American Heart Association Scientific Sessions 2007, Orlando, FL, 7 November 2007

Today we have smokers risking serious adverse events with Chantix when statistically Chantix has failed to prevail in generating more quitters than the nicotine patch at either six months or one year, when Chantix has never gone head-to-head with cold turkey quitters, and when real-world quitters are not receiving the the record 25 counseling/support sessions received by study participants. Frankly, to this day, no one on earth can tell us Chantix's worth as a stand-alone quitting aid when used without record levels of counseling and support.

Imagine a depression medication's worth being evaluated while also receiving record levels of counseling and then being sold without it. Consumer fraud calls that a bait and switch tactic, while the pharmaceutical industry calls it smart business.

What next? Now we wait for the Phase III Nabi "not-so-blind" clinical trials that are already underway and scheduled to be complete in early 2012.

If you've found this article and Freedom via a search engine we encourage you to stay, explore and read as knowledge is power! What you'll discover is that there was always only one rule that if followed provides a 100% guarantee of success .... no nicotine just one hour, challenge and day at a time! Yes you can!

Breathe deep, hug hard, live long,

John (Gold x11)

Last edited by JohnPolito on July 19th, 2011, 11:15 am, edited 4 times in total.

The below breaking Bloomberg news on Nabi's NicVax vaccine's failure to show effectiveness against placebo injections suggests two things: (1) millions of nicotine addicts are in need of a new "coming magic cure" justification for putting off quitting, and (2) the vaccine's defeat was likely significantly worse than reported.

What few appreciate is that lies about coming magic cures feed the biggest lie of all, that life without smoking nicotine would be horrible. What few smokers understand is that nicotine addiction is a brain wanting disorder, a mental illness and disease as real, permanent and gripping as alcoholism. What most claimed by their addiction fail to discover while still time is "The Law of Addiction," why one is always too many and a thousand never enough.

So why are the below results likely worse than reported? Because the study also offered participants ongoing counseling and support which we know has its own proven effectiveness.

So why did the placebo group do so poorly? Because experienced quitters joined this study seeking a way to minimize the withdrawal syndrome they'd felt during prior attempts and instead things felt the same. Contrary to quitting study assertions, for smokers with lengthy quitting histories placebo-controlled smoking cessation studies are not blind as they have become experts at knowing exactly how withdrawal feels.

If you'd joined a six injection vaccine study that promised that smoked nicotine would no longer be able to cross your blood-brain barrier to satisfy the wanting within, would you have stuck around and endured five more injections if you felt nicotine fully satisfy your wanting, just as it had done thousands of times before? Neither did they. And their early surrender after recognition that they'd been assigned to receive sugar-water placebo injections made the vaccine look far superior to its real worth.

If you are a smoker who has stumbled upon this article at Freedom, we hope and pray that you don't leave until you've read the most important quitting lesson of all, "The Law of Addiction." We hope you'll bookmark www.WhyQuit.com and return to spend a time exploring, that you'll watch our free quitting videos in Joel's Library, and that once ready for serious support you'll visit us again here at Freedom from Nicotine.

Contrary to the message flowing from your hijacked brain dopamine pathways and the thousands of old nicotine replenishment memories they've helped record, coming home to the real you can be the most liberating and glorious journey you'll ever make! Remember, there's just one rule to successful quitting ... just one puff spells defeat. Just one rule ... no nicotine just one hour, challenge and day at a time!

Bloomberg - By Oliver Renick - Jul 18, 2011 1:03 PM ET
Nabi Biopharmaceuticals (NABI), the developer of a vaccine for nicotine addiction, plunged to a 13- year low in Nasdaq trading after the treatment for smoking cessation failed to show effectiveness.

Nabi, based in Rockville, Maryland, dropped $1.75, or 69 percent, to $1.75 at 12:53 p.m. New York time in Nasdaq Stock Market trading, after earlier declining to $1.55, the lowest price since October 1998.

The drug, NicVAX, is an experimental vaccine aimed at aiding smoking cessation and preventing relapses in recovering smokers. NicVAX didn’t help smokers quit in the first of two Phase 3 clinical trials designed to evaluate effectiveness, Nabi said today in a statement.

“NicVAX is dead as currently configured,” Jeffrey Cohen, senior analyst at CK Cooper & Co. in Irvine, California, said in an interview. “Nabi’s recovery is somewhat unrealistic.”

Cohen has a “buy” rating that is under review, he said. He doesn’t own the stock.

Subjects using NicVAX quit smoking at a similar rate of 11 percent compared with subjects who received a placebo treatment, the company said. The study was part of the last of three stages of clinical trials generally required for U.S. regulatory approval.

Nabi is currently conducting a second round of Phase 3 trials that will analyze today’s results, President and Chief Executive Officer Raafat Fahim said in a webcast.

“We hope that our analysis over the next little while will shed light on the reasons for such surprising results,” Fahim said. “The trial was very well conducted.”

Nabi formed an exclusive option and license agreement for NicVAX with London-based GlaxoSmithKline Plc (GSK) in March 2010 that entitled Nabi to receive $20 million upon the successful completion of Phase 3 trials and up to $460 million in potential option fees.